Recall Z-0043-2017— Trumpf Medical Systems, Inc.

Class II · Terminated

Class II FDA medical device recall by Trumpf Medical Systems, Inc., initiated 2016-07-10, terminated 2017-03-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system. Reason: Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters..

Recalling firm
Trumpf Medical Systems, Inc.
Classification
Class II
Status
Terminated
Initiated
2016-07-10
Terminated
2017-03-02
Firm location
Charleston, SC, United States

Product description

Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system

Reason for recall

Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.

Data sourced from openFDA. This site is unofficial and independent of the FDA.